BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIGULLA FLEX II ASD OCCLUDER

    MDR report key: 23062206 · Received September 16, 2025

    Report

    Report Number
    3014616394-2025-00020
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    August 8, 2025
    Report Date
    January 16, 2026
    Manufacturer
    OCCLUTECH GMBH
    Product Code
    OZG
    UDI-DI
    0426018520710
    PMA / PMN Number
    P200032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ASSOCIATED DEVICE: BRAND NAME: PISTOL PUSHER; MODEL NUMBER: 55PP185, SERIAL NUMBER: (B)(6) AND A4 ARE UNKNOWN. THE REVIEW OF THE BATCH RECORD AND INSPECTION PROTOCOLS OF THE REPORTED DEVICE REVEALED NO DEVIATION. NO OTHER COMPLAINT EXISTS FROM THE REPORTED LOT REGARDING THE SAME COMPLAINT REASON. ALL QC CRITERIA WERE WITHIN SPECIFICATION ACCORDING TO THE BATCH RECORD. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE BATCH RECORD REVIEW, INSPECTION PROTOCOLS AND THE PACKAGING OF THE COMPLAINED DEVICES 29ASD24; 2439292408_22 REVEALED NO DEVIATIONS. THE FINAL INSPECTION OF THE COMPLAINED ASD REVEALED NO DEVIATIONS AND THE ENVIRONMENTAL CONDITIONS DURING THE STORING WERE WITHIN LIMITS. DURING THE INVESTIGATION, IT WAS POSSIBLE TO GRAB AND RELEASE THE OCCLUDER WITHOUT ANY ISSUE. BALL-JAW CONNECTION WITHSTAND A TUG TEST.I T WAS CONCLUDED THE OCCLUDER INDEED IS COMPATIBLE WITH THE PUSHER.WITH THE DEVICES BEING COMPATIBLE WITH EACH OTHER AND WITHSTANDING A TUG TEST, A DEVICE-RELATED FAILURE CAN BE EXCLUDED. IT IS POSSIBLE THE COMPLAINED EVENT OCCURRED DUE TO THE APPLICATION OF EXCESSIVE FORCES ONTO THE PUSHER. ANOTHER POSSIBILITY THAT THE PUSHER CABLE WAS NOT SET TO A STRAIGHT LINE, WHICH CAN CAUSE NOT-REPRODUCIBLE ISSUES WITH THE CLOSING MECHANISM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE PUSHER AUTO RELEASED DEVICE BEFORE INSERTION, DESPITE THE PUSHER BEING LOCKED. THE PUSHER WORKED AFTER PUSHING THE TRIGGER SEVERAL TIME. PROCEDURE CONTINUED BUT THE DEVICE WAS UNDERSIZED, THE DEVICE WAS RETRACTED. THE PUSHER WAS JAMMED WHEN TRYING TO RELEASE THE DEVICE OUTSIDE THE INTRODUCER. THE THE TRIGGER WAS PUSHED SEVERAL TIME TO RELEASE THE DEVICE. AFTER THAT THE PUSHER JAMMED AGAIN DESPITE PUSHING THE TRIGGER SEVERAL TIMES. NO PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: THE PUSHER AUTO RELEASED DEVICE BEFORE INSERTION, DESPITE THE PUSHER BEING LOCKED. THE PUSHER WORKED AFTER PUSHING THE TRIGGER SEVERAL TIME. PROCEDURE CONTINUED BUT THE DEVICE WAS UNDERSIZED, THE DEVICE WAS RETRACTED. THE PUSHER WAS JAMMED WHEN TRYING TO RELEASE THE DEVICE OUTSIDE THE INTRODUCER. THE THE TRIGGER WAS PUSHED SEVERAL TIME TO RELEASE THE DEVICE. AFTER THAT THE PUSHER JAMMED AGAIN DESPITE PUSHING THE TRIGGER SEVERAL TIMES. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2673675 FIGULLA FLEX II ASD OCCLUDER ASD OCCLUDER OZG OCCLUTECH GMBH 29ASD24 2439292408 0426018520710

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female